Pentax of America Inc Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

Recommended Action

Per FDA guidance

Pentax issued Urgent Medical Device Correction letter via UPS mailing on 7/14/21. Letter states reason for recall, health risk and action to take (USB drive along with the enclosed instruction sheet enclosed). Letter states: PENTAX separated the EC and EG rIFUs into 5 separate rIFUs . The grouping will allow the following for reprocessing personnel: " Eliminate the need to identify optional configurations of instrument channels and water jet channels " Simplify the instructions and graphics in the individual rIFUs Please replace any previous versions of rIFUs with the most current revision. Please note that this documentation set is current as of this date. For future updates, please refer to the PENTAX online IFU library at https://ifu.pentaxmedical.com. Customer Instructions: Please complete the enclosed Field Correction Response Form upon receipt of this package, and email to PENTAX at customeradvisories@pentaxmedical.com. Questions regarding this action, please feel free to contact us at: o Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) o Fax: 201-799-4063 (alternate 201-391-4189) o Email: customeradvisories@pentaxmedical.com